Drug Approvals

Biogen announces surprise submission for Alzheimer’s drug approval

Oct 22, 2019

Earlier this year, Biogen and its partner, Eisai Co Ltd, abandoned a set of trials for an Alzheimer’s treatment after the data showed it wasn’t likely to meet its goals. But in a stunning reversal this week, Biogen announced that new data from the discontinued  studies revealed that in high doses the drug, aducanumab, can improve several markers of cognitive disfunction. Biogen said it is now resurrecting its hope that the drug could become a blockbuster, and will seek FDA approval for the medication early next year.

According to the company, patients in the study experienced an improvement in memory function, orientation and language while taking aducanumab. But one analyst told Reuters that the data was not compelling enough for an easy approval, and that Biogen is going to have a tough time convincing the FDA that the results were not random. 

Nevertheless, news of the approval submission sent shares soaring for Biogen, which has been on the hunt for new growth-drivers. There are still no treatments approved by the FDA that have been shown to slow the progression of Alzheimer’s.

Read the Reuters report.